Yield & Quality

The continuous Improvement drive to increase the conversion of each chemical transformation towards the theoretical yield has jumped the overall yield by 30%. This achieved the conversion of each stage by not less than 75% , which has resulted to reduce the RMC by 21%.

In depth review of the trend analysis about the unknown impurities has found an amazing outcome. Imparted training to the key persons to adhere the stringent conditions of the process in Batch manufacturing Record. This also was supported with the revision of SOP. This has eliminated the root cause of unknown impurity in more than 25 Intermediates and APIs.

During the process development , critical process parameters (CPP)  have been  studied and witnessed. Before Pilot Trials the thorough Quality Risk Assessment (QRA) further reviewed  CPP in detail . With this approach, successfully completed the validations, right at first time in more than 20 APIs at Pilot & Commercial Scale..   .

To study the impact of multiple variables using DOE has given ideas to change the ways of operations in many manufacturing processes. These positive changes have stabilized the Quality & Yield in many APIs and intermediates.

Detailed study of annual quality review (QMS) gives many ideas about generation of impurities during the process and from KSM source. This triggers to track the ROS or process changes at supplier end (if any) and ensure the delivery of consistent quality of KSM and RM. This is one of the issue of frequent failures addressed in many APIs.

The frequent OOT issues like variations in KF, LOD, Residual solvent, % of solvents in distillations were addressed by studying the respective SOPs. Modified the Operating procedures to reduce the OOT trend and  the switch over of OOT to OOS..

Effective CAPA implementation is the challenge in the industry. For the successful CAPA implementation, the focus on inherent process, operational and allied issues should be segregated properly. This will direct towards the accurate root cause analysis, report writing and execution.

Discussed the CAPAs with FDA inspector and many other regulatory authorities & convinced.